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NCT04797637 · ClinicalTrials.gov registry record · NA
Post-operative Patient Positioning Device for Improvement of Post-Operative Pain
A NA study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 278
- Enrollment target
NCT04797637: Completed NA study, sponsored by Vanderbilt University Medical Center.
NCT04797637 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 278 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04797637, a NA study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 278 participants
- Enrollment target
Study Summary
This paucity of evidence supporting or dissuading the use of postoperative abdominal support following cesarean section for the reduction of postoperative pain leaves important clinical questions unanswered. Additionally, there is an absence of long-term outcomes associated with the use of abdominal support devices. There remains a need for the development and implementation of nonpharmacologic methods for analgesia for women following cesarean sections, along with evidence-based recommendations regarding their use in postoperative patients. The ABBy (G-Squared Medical, Brentwood, TN) is an extended-wear panniculus retractor/tissue stabilizer that is intended for use postoperatively after abdominal procedure. It is placed directly onto patient skin, superior to a transverse incision, and is then used to elevate redundant tissues away from an incision or wound (https://www.gsquaredmedical.com/How-it-Works.html). The ABBy can be removed and replaced by patients and can be used for up to 10 days. This study aims to assess the effect of ABBy use on postoperative pain, pain medication requirement, and patient satisfaction, when used as a patient-positioning device in women following cesarean delivery.
Primary Outcome
Postoperative analgesia will be administered to all participants as per routine guidelines on postpartum.
Interventions
- DEVICE ABBy® Adjustable Panniculus Retractor for Wound Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 278 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2022-07-20 |
| Phase | NA |
What the finished NCT04797637 record still lists
NCT04797637 is an interventional study that assigns participants to a tested intervention. The registered 278 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which ABBy® Adjustable Panniculus Retractor for Wound Care is the first listed.
NCT04797637 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04797637 about?
NCT04797637 is a clinical study titled "Post-operative Patient Positioning Device for Improvement of Post-Operative Pain". This paucity of evidence supporting or dissuading the use of postoperative abdominal support following cesarean section for the reduction of postoperative pain leaves important clinical questions unanswered. Additionally, there is an absence of long-term outcomes associated with the use of abdominal...
What is the current status of trial NCT04797637?
This trial is currently completed. It is a NA study. The enrollment target is 278 participants. The study started on 2021-04-01. Estimated completion is 2022-07-20.
What interventions are being tested in trial NCT04797637?
The interventions under investigation include: ABBy® Adjustable Panniculus Retractor for Wound Care (DEVICE).
Who is sponsoring clinical trial NCT04797637?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04797637's enrollment target sits among peer trials
278 382nd of 2000 higher than 1,618 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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